1. Field of the Invention
The present invention relates generally to a system for recruitment of candidates for clinical trials, and in particular to the recruitment of candidates, such as individuals who are afflicted with AIDS/HIV positive, who require a certain level of privacy concerning access to their personal and medical information. The invention is also directed to a method of using the same.
2. Description of Related Art
Before a drug or medical technique is approved for use on the public at large, it is administered to a limited number of patients who participate in clinical trials. It is necessary when selecting individuals to participate in the clinical trials to choose only those individuals who meet particular exclusion and inclusion criteria for a specific trial. Selection of candidates to participate in such clinical trials may depend on factors, such as the gender, age, symptoms, prognosis, and previous medical treatments.
Conventional methods of solicitation, such as newspaper and magazine advertisements have heretofore been widely used to solicit individuals to participate in clinical trials. By way of example, an advertisement may be directed to individuals who suffer from asthma and are currently on steroids. Individuals who meet the requirements specified in the advertisement are invited to call a particular number or inquire to be considered as a candidate to participate in the clinical trial.
With the advent of the Internet, web sites, such as Koop.com, Americasdoctor.com and Intertrials.com, have electronically implemented the conventional solicitation process for on-line recruitment of candidates for clinical trials. The procedures used by these conventional web sites, however, are not suitable for receiving personally identifiable medical data concerning patients who suffer from diseases, ailments, disorders, and medical conditions, such as HIV/AIDS, that require a certain level of security against potential unwanted dissemination of personal and/or medical information, and the right to remove one's name from a list of volunteers. Not only is the privacy of such data desirable from the point of view of the individual and their family, but legislation and regulations mandate the level of security to be accorded personal and medical information. For example, the federal department of Health and Human Services has recently promulgated regulations concerning the level of security to be accorded transmission of medical records and personal data, and in particular New York legislation requires that prior to dissemination of medical information the individual sign a release form and that an opt out method be available when recruiting candidates for clinical trials. Other countries have recently adopted guidelines, such as the European Union data directive concerning procedural aspects of the dissemination of personal and medical information.
It is therefore desirable to develop a system and method for online recruitment of candidates for clinical trials and research studies that overcomes the aforementioned problems.